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510(k) K935389

CONMED VENI-GARD I.V. DRESSING by Conmedcorp — Product Code KMK

K935389 is an FDA 510(k) premarket notification submitted by Conmedcorp for the device "CONMED VENI-GARD I.V. DRESSING". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Conmedcorp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
November 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type

Other clearances by Conmedcorp

  • K101534 — CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (November 24, 2010)
  • K061021 — ENTAKE STANDARD AND SAFETY PEG SYSTEM (April 28, 2006)
  • K050992 — CONMED IRRIGATION NOZZLE (July 14, 2005)
  • K050777 — PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 (April 22, 2005)
  • K050304 — FX WIRE ADVANCED MEASUREMENT GUIDEWIRE (March 8, 2005)
  • K041953 — VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART (August 9, 2004)
  • K021079 — ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX (July 1, 2002)
  • K021299 — CONMED HEATWAVE HAND-CONTROLLED ELETRODE (June 26, 2002)
  • K020186 — CONMED SYSTEM 5000 ESU (April 12, 2002)
  • K020135 — CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF (April 12, 2002)

Other clearances for product code KMK

  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec (July 9, 2019)
  • K981860 — A P HARNESS (June 3, 1999)
  • K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER (October 11, 1996)
  • K941098 — SECURE-SITE (August 9, 1995)
  • K943147 — STATLOCK CV (September 29, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE (July 14, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (February 18, 1994)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)

FDA data resources